Key elements of ISO 9001
ISO 9001 is based on the PDCA cycle – Plan-Do-Check-Act - and its key elements are:
- Establishing the quality management system
- Documenting the system
- Implementing the system
- Reviewing the results
- Maintaining the system
Improving the system.
Establishing an effective QMS
After purchasing ISO 9001, the first step towards a practical QMS is to identify your processes.
This can best be achieved by initially focusing on two broad categories, management and operations, then working out which processes flow from these.
Thereafter, it will be necessary to:
- Set out the criteria (aligned with the quality policy) by which the success of each process can be measured
- Work out which processes are interrelated
- Develop a system to check the results.
Each process should have an ‘owner’ who is responsible for monitoring and reporting on its success against the selected criteria.
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Documenting your QMS
ISO 9001 requires four tiers of documentation:
- A Quality Policy Manual setting out the direction of the QMS, including definitions, scope, objectives and necessary human and material resources
- A Procedure Manual describing the implementation of the policies, including detail such as areas of responsibility, linkages and workflow
- Work Instructions defining how specific tasks are to be performed
- Records including minutes, audits, reviews, test results, specifications, invoices and costs (the Standard sets out a comprehensive list of required records).
Implementing your QMS
Before you can assess the effectiveness of any QMS, it must first be put into practice. Every organization is different and the exact procedures will vary, depending on the size, scope and nature of your activities.
It is important to systematically implement the details as agreed: forms, equipment, instructions, allocation of personnel, etc.
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Reviewing your QMS
At appropriate intervals, the results of the QMS should be reviewed.
When the system is first up and running, it will be necessary to conduct reviews at short intervals, so that teething problems can be rectified early. After the QMS has matured, the intervals between reviews can be lengthened.
A key milestone in evaluating the QMS is the management review, a meeting which assesses whether the QMS has succeeded in meeting:
- Strategic objectives
- Process success criteria
- ISO 9001 requirements.
Maintaining your QMS
Every business will confront obstacles and challenges.
Success or failure can hinge on identifying these at an early stage and dealing with them effectively. Records should be designed to allow for the early detection and prompt reporting of problems.
As part of maintaining a QMS, businesses should continually monitor customer satisfaction. On its own, a system of handling complaints won’t necessarily be enough to prevent customers transferring their business to a competitor. It is vital to eliminate, or at least reduce, the volume of customer complaints and raise positive customer perceptions.
Improving your QMS
Improvement involves pinpointing challenges, actual and potential, and fixing them.
Actual problems that have occurred – e.g. a late delivery – should be rectified by what ISO 9001 refers to as a ‘corrective action’.
A corrective action may involve an actual customer complaint, a difficulty with a supplier or a faulty product. All corrective actions must be recorded.
Potential problems that have been identified as a result of a near miss – e.g. almost failing to make a delivery – should be tackled by what ISO 9001 defines as a ‘preventive action’.
Preventive actions can be handled in a similar way as corrective actions, though small companies may prefer to handle preventive action as part of their management review.